MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	MICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Word order search: no similar complaint type events were reported for units within the same lot.Device evaluation: lens was returned dry, in a specimen cup, with clear surgical residue on product.Visual inspection found no visible damage to lens.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm micl13.2, -15.0 diopter, implantable collamer lens was removed from the patients eye because it was too big.The lens was later exchanged (different surgery) with a smaller lens and the problem was resolved.
Additional Manufacturer Narrative
Additional information was received.The reporter stated the lens was implanted into the patients right eye (od) on (b)(6) 2018, removed on (b)(6) 2018 and exchanged intraoperative due to excessive vault and significant reduction of irido-corneal angles.This exchange did not resolve the problem.Choosing icl length shorter than recommended by calculator (wtw confirmed) still produced excessive vault.Iop remains good, cornea healthy.Will observe.Note: significant icl diopter power change noted.This was result of pre-op measurement, reliance on mrx rather than contact lens over-refraction, and was corrected with the second surgery.I believe this is independent from the issue of excessive vault.Wtw measured on multiple occasions using digital calipers.(b)(4).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 7791738
• Report Number: 2023826-2018-01234
• Device Sequence Number: 16523374
• Product Code: MTA
• UDI-Device Identifier: 00841542103398
• UDI-Public: 00841542103398
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR